ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF FLUNISOLIDE IN NASAL SPRAY FORMULATION BY RP-HPLC
Abstract
Objective: The objective of the present research work was to develop and validate reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantification of flunisolide in nasal spray formulations.
Methods: The developed method was validated according to International Conference on Harmonisation (ICH) guideline with respect to system suitability, accuracy, precision, specificity, linearity, and robustness. An isocratic condition of mobile phase comprising phosphate buffer (pH 5.5): acetonitrile: tetrahydrofuran in a ratio of 73:15:12, v/v at a flow rate of 1.0 ml/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 µm, Phenomenex Inc.) column at ambient temperature was maintained.
Results: The method showed excellent linear response with correlation coefficient (R2) values of 0.999, which was within the limit of correlation coefficient (R2≥ 0.995). Intra and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation %RSD ≤ 2.0.
Conclusion: A simple reversed-phase HPLC method for the analysis of flunisolide in nasal spray formulations was developed and validated.
Keywords: Flunisolide, ICH, Nasal Spray, RP-HPLC, Validation
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References
Durham SR. The inflammatory nature of the allergic disease. Clin Exp Allergy 1998;28 Suppl 6:20-4.
Meltzer EO. Formulation considerations of intranasal corticosteroids for the treatment of allergic rhinitis. Ann Allergy Asthma Immunol 2007;98:12-21.
Lieberman P. Management of allergic rhinitis with a combination antihistamine/anti-inflammatory agent. J Allergy Clin Immunol 1999;103:S400-4.
Giger R. Comparison of once-versus twice-daily use of beclomethasone dipropionate aqueous nasal spray in the treatment of allergic and non-allergic chronic rhinosinusitis. Arch Oto-Rhino-Laryngol 2003;260:135-40.
Amanda J. Intranasal corticosteroids for allergic rhinitis. Pharmacotherapy 2002;22:11-2.
Schmidt BM. The new topical steroid ciclesonide is effective in the treatment of allergic rhinitis. J Clin Pharmacol 1999;39:1062-9.
Scadding GK, Keith PK. Fluticasone furoate nasal spray consistently and significantly improves both the nasal and ocular symptoms of seasonal allergic rhinitis: a review of the clinical data. Expert Opin Pharmacother 2008;9:2707-15.
Kleinjan A. Preventive treatment of intranasal fluticasone propionate reduces cytokine mRNA expressing cells before and during a single nasal allergen provocation. Clin Exp Allergy 2000;30:1476-85.
Hochhaus G. Pharmacokinetic/pharmacodynamic profile of mometasone furoate nasal spray: potential effects on clinical safety and efficacy. Clin Ther 2008;30:1-13.
Condemi J, Schulz R, Lim J. Triamcinolone acetonide aqueous nasal spray versus loratadine in seasonal allergic rhinitis: efficacy and quality of life. Ann Allergy Asthma Immunol 2000;84:533-8.
Bernstein JA. Azelastine hydrochloride: a review of pharmacology, pharmacokinetics, clinical efficacy and tolerability. Curr Med Res Opin 2007;23:2441-52.
Shah SR. Effects of olopatadine hydrochloride nasal spray 0.6% in the treatment of seasonal allergic rhinitis: a phase III, multicenter, randomized, double-blind, active-and placebo-controlled study in adolescents and adults. Clin Ther 2009;31:99-107.
Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics. US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER); 2015.
Rxlist. Com. RxList Inc; c2015-06. Available from: http://www.rxlist.com/nasalide-drug.htm. [Last accessed on 14 Dec 2015].
Kartheek N, Kavitha N, Ashok Kumar A. RP-HPLC method development and validation for simultaneous quantitative estimation of diloxanide furoate and tinidazole in tablets. Int J Pharm Pharm Sci 2015;7:338-42.
ICH Harmonised Tripartite Guideline Validation of Analytical Procedures: Text And Methodology Q2(R1); 1996.
Jadhav MP, Tanga Y, Hochhausa G. Development and validation of liquid chromatography-tandem mass spectrometry method for detection and quantification of flunisolide in tissue culture medium. Analytical Letters 2013;46:1355-63.
Pharmacopeia. cn. United States Pharmacopeia (USP); 2008-10. Available from: http://www.pharmacopeia.cn/ v29240/ usp29nf24s0_m33405.html. [Last accessed on 14 Dec 2015].